FDA Orange Book · active-ingredient family
Dapagliflozin; saxagliptin hydrochloride
Dapagliflozin; saxagliptin hydrochloride is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:QTERN · NDA 209091
1
Brand (NDA)
2
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QTERNRLD×2 | ASTRAZENECA AB | NDA 209091 | — | May 02, 2019 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE | MSN | ANDA 211533 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE | TORRENT | ANDA 211537 | AB | Apr 06, 2026 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6515117 | Oct 04, 2025 | 9 mo ago | SubstanceProductU-493 |
| 6515117*PED | Apr 04, 2026 | 3 mo ago | |
| 8501698 | Jun 20, 2027 | in 1 yr | ProductU-493 |
| 8501698*PED | Dec 20, 2027 | in 1 yr 6 mo | |
| 8361972 | Mar 21, 2028 | in 1 yr 9 mo | U-493 |
| 8716251 | Mar 21, 2028 | in 1 yr 9 mo | Product |
| 8221786 | Mar 21, 2028 | in 1 yr 9 mo | Product |
| 8221786*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8716251*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 8361972*PED | Sep 21, 2028 | in 2 yr 4 mo | |
| 7919598 | Dec 16, 2029 | in 3 yr 7 mo | Substance |
| 7919598*PED | Jun 16, 2030 | in 4 yr 1 mo |
Dapagliflozin; saxagliptin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
